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Frequency Doubled Q-switched Nd-YAG Laser

by Lutronic Corporation South Korea EUDAMED

Ref SPECTRA XT EMDN Z12011017

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10106EA Basic UDI-DIDate14 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Frequency Doubled Q-switched Nd-YAG Laser
Model / Reference
SPECTRA XT
Primary DI / UDI-DI
D-10106EA
Basic UDI-DI
B-10106EA
EMDN Code
Z12011017 Neodymium surgical laser
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000009035
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Lutronic Corporation

See all devices from Lutronic Corporation →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b0817ddc-a443-4a96-96fe-9d87d2ac0ecd 61 fields · synced 25 Oct 2026